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Ket-1
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref S11004, S11008, S11009
Identity
- Trade Name
- KET-1 EUDAMED
- Device Name
- KET-1 Blood Ketone Monitoring System EUDAMED
- Model / Reference
- S11004, S11008, S11009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487609A06R EUDAMED
- Basic UDI-DI
- B-47136487609A06R EUDAMED
- EMDN Code
- W0101060110,W020106019099 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
The KET-1 Blood Ketone Monitoring System (BMKMS) is a self-testing device designed for in vitro diagnosis of ketosis. It features an advanced sensor technology, allowing for accurate and precise measurements of blood ketone levels. The system is compatible with various analyzers and offers reliable and consistent results.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-47136487609A06R | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 812162c0-cdf9-4c57-b42c-6b1d788cb346 61 fields · synced Jul 7, 2026